Name | Ketotifen fumarate |
CAS number | 34580-14-8 |
EINECS number | 252-100-0 |
Related CAS# | 34580-14-8 (fumarate); 34580-13-7 (free base) |
Synonym | Ketotifen; Ketotifene; Zaditor; Zaditen; Ketotiphen; 4-(1-methylpiperidin-4-ylidene)-4,9-dihydro-10H-benzo[4,5]cyclohepta[1,2-b]thiophen-10-one fumarate |
Description | Ketotifen is a second-generation noncompetitive H1 antihistamine and mast cell stabilizer. It is most commonly sold as a salt with fumaric acid, ketotifen fumarate, and is available in two forms. In its ophthalmic form, it is used to treat allergic conjunctivitis, or the itchy red eyes caused by allergies. In its oral form, it is used to prevent asthma attacks. |
Structure |  |
Molecular Formula | C23H23NO5S |
Molecular Weight | 425.5 g/mol |
Appearance | Solid powder |
Quality Standard | EP/BP Standard |
Assay | ≥98% |
Shipping Condition | Shipped under ambient temperature as non-hazardous chemical. This product is stable enough for a few weeks during ordinary shipping and time spent in Customs. |
Storage Condition | Store in cool place. Keep container tightly closed in a dry and well ventilated place. |
Shelf Life | >2 years if stored properly |
Sample package | Aluminium foil bag |
Commercial package | Aluminium Tin, Fiber drum |
Origin | China |
HS Code | 2934999099 |
Ketotifen fumarate More Info
Ketotifen fumarate is a pharmacological agent primarily used as an antihistamine and mast cell stabilizer. It is effective in managing allergic conditions such as allergic conjunctivitis, asthma, and urticaria (hives). The drug is available in various formulations, including oral tablets and ophthalmic solutions.
Mechanism of Action
Ketotifen exerts its effects through multiple mechanisms:
Histamine H1 Receptor Antagonism: It acts as a non-competitive antagonist at the H1 receptor, preventing the action of histamine, a key mediator in allergic responses.
Mast Cell Stabilization: Ketotifen inhibits the release of inflammatory mediators from mast cells, including histamine and leukotrienes, thereby reducing the severity of allergic reactions.
Inhibition of Eosinophil Activation: It prevents the accumulation and activation of eosinophils in allergic conditions, which contributes to inflammation and tissue damage.
These combined actions make ketotifen effective in alleviating symptoms associated with allergies and asthma.
Applications
Ketotifen fumarate is indicated for:
Allergic Conjunctivitis: Used to relieve itching and redness of the eyes caused by allergies.
Asthma Management: As an adjunct therapy to reduce the frequency and severity of asthma attacks.
Urticaria (Hives): Effective in managing symptoms associated with chronic urticaria.
Other Allergic Conditions: Such as allergic rhinitis and dermatitis.
Routes of Administration
Ketotifen fumarate is available in several forms:
Oral Tablets: Commonly prescribed for systemic use in managing allergies and asthma.
Ophthalmic Solution: Used for localized treatment of allergic conjunctivitis.
The typical dosage for oral administration ranges from 1 mg to 2 mg twice daily, while the ophthalmic solution is usually applied as one drop in each affected eye twice daily.
Safety and Side Effects
Common Side Effects
Patients using ketotifen may experience:
Drowsiness or sedation
Dry mouth
Nausea
Headache
Eye irritation (for ophthalmic formulations)
Serious Side Effects
More severe adverse effects can include:
Allergic Reactions: Symptoms such as rash, itching, swelling, or difficulty breathing.
Severe Dizziness or Fainting: Indicating potential cardiovascular effects.
Liver Dysfunction: Rarely reported but may manifest as jaundice or elevated liver enzymes.
Precautions
Caution is advised for individuals with a history of liver disease or those taking other medications that may interact with ketotifen. Regular monitoring is recommended during treatment.
Pharmacokinetics
Absorption and Distribution
Ketotifen is well absorbed from the gastrointestinal tract after oral administration, with peak plasma concentrations reached within 2 to 4 hours. The bioavailability is approximately 50% due to first-pass metabolism.
Metabolism and Excretion
The drug undergoes hepatic metabolism and is primarily excreted through urine. The elimination half-life is about 12 hours, allowing for convenient dosing schedules.
Special Considerations
Patients should be aware that ketotifen may cause drowsiness; therefore, caution should be exercised when driving or operating machinery until they know how it affects them.
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